MAUDE Adverse Event Report: ANSELL N.P. SDN. BHD. ANSELL GAMMEX NON LATEX PI; SURGICAL GLOVES

Model Number 816734

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Tachycardia (2095); Burning Sensation (2146)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicated no abnormalities were found.Production records show that lot met the standard requirement prior to shipment release.The lot passed all the required inspections and criteria were performed according to the established procedures.No significant changes were made to the manufacturing process.Glove formulation was modified to reduce the risk of type iv allergy by eliminating certain higher risk chemicals (mainly accelerators) from the formulation and to ensure compliance with an ever more stringent regulatory environment.Returned and retained sample analysis show no abnormalities.Fit kit test that measures major allergens was performed with no detection determined.This indicates a very low probability that the gloves could have cause an allergic reaction.Chemical residue test measuring presence of accelerators and antioxidants residue show no abnormalities were found.Based on the investigation, there were no deviations nor evidence of special causes that would have led to an allergic reaction.As a result, no corrective action was rendered at this time.

Event Description

Incident occurred on (b)(6) 2018 in (b)(6).The customer states an employee experienced an allergic reaction while wearing ansell gammex non-latex pi surgical gloves and developed a burning/itching sensation and pink rash on her hands.The rash spread to her upper arms and then to her chest with welts.The employee was treated in the emergency room for an allergic reaction.She had elevated heart rate despite treatment and was admitted to icu due to tachycardia.She was discharged from icu after 2-3 nights.

• Brand Name: ANSELL GAMMEX NON LATEX PI
• Type of Device: SURGICAL GLOVES
• Manufacturer (Section D): ANSELL N.P. SDN. BHD.; lot 80 kawasan; melaka, 75450 ; MY 75450
• MDR Report Key: 8438033
• MDR Text Key: 139416692
• Report Number: 3011209798-2019-00001
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/20/2021
• Device Model Number: 816734
• Device Catalogue Number: 20685765
• Device Lot Number: 1804450404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Distributor Facility Aware Date: 11/27/2018
• Event Location: Other
• Date Report to Manufacturer: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization